MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AHX500H11

Device Problem Calcified (1077)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

Event Description

The manufacturer received information regarding a dreamstation auto cpap device.The device was returned to a third party service center.During visual inspection of the device there was no evidence of foam degradation.However, white particles were found in the device.The device was scrapped.This report is being submitted for the white particles found during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18578986
• MDR Text Key: 333723861
• Report Number: 2518422-2024-04076
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022560
• UDI-Public: 00606959022560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AHX500H11
• Device Catalogue Number: AHX500H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1